Pfizer-J&J Drop Alzheimer’s Drug Studies After Failure

Aug. 7 (Bloomberg) -- Pfizer Inc., Johnson & Johnson and
Elan Corp. ended most plans to develop an Alzheimer’s drug after
a second trial failure, a blow to the companies’ efforts to
market the first product to slow progress of the disease.

Bapineuzumab, designed to attack the brain plaques that
serve as a hallmark of Alzheimer’s, failed to improve symptoms
of dementia in the second of four final-stage trials of the
drug, Pfizer and J&J said yesterday in statements.

Drugmakers have been trying for more than a decade to find
therapies to slow Alzheimer’s. While companies have focused on
developing drugs to hinder the amyloid deposits, scientists
aren’t certain whether the clumps cause or are a minor
contributor to the disease or merely a consequence.

“Alzheimer’s is a tough nut for any drug company to
crack,” said Erik Gordon, a professor at the University of
Michigan’s Ross School of Business, in an e-mail. “We don’t
know for sure what causes it or even what it really is. There
will be more failures before we see a success.”

Pfizer shares declined 2.1 percent to $23.74, while J&J
decreased less than 1 percent to $68.29. Dublin-based Elan’s
American depositary receipts sank less than 1 percent to $11.15.

In the Pfizer-J&J trial, bapineuzumab didn’t help patients
who don’t have a gene, called ApoE4, that boosts the risk of
getting the disease. New York-based Pfizer announced on July 23
that a final-stage study of the product failed in patients with
the ApoE4 gene.

Pfizer Focus

Pfizer, the world’s biggest drugmaker, has been shedding
units, cutting costs and focusing on therapies in development as
Chief Executive Officer Ian Read tries to refocus the world’s
largest drugmaker on its core mission to replace revenue lost
when its best-selling cholesterol pill Lipitor began facing
generic competition last November.

“We believe the bapi program is shut down and the company
has no plans to file for approval based on the data thus far,”
Mark Schoenebaum, an analyst at ISI Group, wrote in a research
note about Pfizer, using the drug’s nickname. “The company has
very likely already analyzed subgroups and found no signal that
they believe could lead to a commercial future at this time.”

Lilly Failure

Bapineuzumab isn’t the first experimental Alzheimer’s drug
against amyloid that has failed in a large trial. In August
2010, an experimental drug from Eli Lilly & Co. that attacked
amyloid in a different way failed to improve cognition in two
large studies, prompting Lilly to stop developing the product.

Until the bapineuzumab trials were stopped yesterday,
Pfizer, Elan and J&J were competing with a second experimental
Alzheimer’s drug from Indianapolis-based Lilly to create the
first therapy to target a cause for Alzheimer’s, rather than
just its symptoms. Trial results for this Lilly therapy are due
soon.

Companies continue to pursue Alzheimer’s drugs in the face
of so many unknowns because “the market is tremendous --
multiple billions,” Les Funtleyder, a fund manager at Poliwogg,
a private equity and hedge fund in New York, said in a telephone
interview.

If a medicine clearly worked to slow the disease, “you
could be talking about the biggest drug ever.”

About 5.4 million Americans have Alzheimer’s, the most
common type of dementia, a number expected to increase to as
many as 16 million people by 2050, according to the Alzheimer’s
Association, a Chicago-based advocacy and research group.

Trial Failure

Numerous reasons may account for the bapineuzumab trial
failures, said Lon Schneider, director of the University of
Southern California Alzheimer’s Disease Research and Clinical
Center in Los Angeles. It could be that intervening earlier in
the disease process is necessary, or that researchers need to
attack amyloid in a different way, he said.

“My wish is that the investor and scientific community
doesn’t interpret this as something to the effect that the
amyloid hypothesis for treatment is invalid or dead,” Schneider
said in a telephone interview. “That’s not the way I’m
interpreting it.”

Elan Charge

Elan will record a non-cash charge of $117.3 million in the
third quarter to write down the value of its stake in the
bapineuzumab program, the company said in a statement.

J&J, based in New Brunswick, New Jersey, said it would take
an after-tax charge of $300 million to $400 million in the third
quarter.

“We are obviously very disappointed in the outcomes of
this trial,” Steven J. Romano, a Pfizer senior vice president,
said in a statement. “We are also saddened by the lost
opportunity to provide a meaningful advance for patients
afflicted with mild-to-moderate Alzheimer’s disease and their
caregivers.”

While all trials of the intravenous form of bapineuzumab in
mild to moderate Alzheimer’s patients will be stopped, a second-stage brain imaging trial of a “subcutaneous version” of
bapineuzumab will continue, Ellen Rose, a J&J spokeswoman, said
in a telephone interview.

Pfizer and its partners may eventually test this version of
bapineuzumab in pre-Alzheimer’s patients, if the results of the
second stage trial are favorable, wrote Tim Anderson, a Sanford
C. Bernstein & Co. analyst in New York, in a note.